Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data

Purpose

This study aims to use vaccination information from state vaccine registries linked with HealthVerity insurance claims for the following: - to measure how effective the Pfizer-BioNTech vaccine is at preventing post-COVID conditions. - to understand characteristics of patients who are receiving COVID-19 vaccines. All patients whose information is kept unidentified in the HealthVerity database are eligible to be included for both aims of this study.

Conditions

  • SARS-CoV-2
  • COVID-19
  • Post-Acute COVID-19 Syndrome

Eligibility

Eligible Ages
Over 6 Months
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Include patients whose claims records and vaccine registry data are both available in the HealthVerity databases 2. Include patients who are eligible to receive the licensed/authorized vaccine during the study period

Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study: 1. Exclude patients with a condition of interest prior to being eligible for the mRNA COVID-19 vaccine booster 2. Receipt of the mRNA COVID-19 vaccine booster prior to date of licensure/authorization (i.e., September 11, 2023 for XBB formulation) 3. Receipt of the licensed/authorized mRNA COVID-19 vaccine prior to being eligible a. Exclude patients who received the licensed/authorized vaccine <2 months since receipt of the most recent prior dose 4. Exclude patients who have had >1 mRNA COVID-19 vaccine dose of the current formulation prior to COVID-19 diagnosis 5. Exclude patients who had a non-Pfizer/BioNTech COVID-19 Vaccine of the current formulation prior to COVID-19 diagnosis 6. Exclude patients who are immunocompromised or pregnant at COVID-19 diagnosis 7. Exclude patients who die or disenroll within 28 days after COVID-19 diagnosis 8. Exclude patients who received a booster less than 14 days before COVID diagnosis 9. Exclude patients who receive a COVID-19 vaccine in the period between index (COVID diagnosis) and start of follow-up (31 days after COVID-19 diagnosis) 10. Exclude persons who had a COVID episode documented within 90 days prior to index, as the index infection is considered a recent reinfection. 11. Exclude persons who have discrepancies in sex and/or year of birth between HealthVerity claims and state Immunization registry datasets.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Patient had Pfizer-BioNTech COVID-19 mRNA vaccine of interest Patient identified in the vaccine registry having one or more dose of Pfizer-BioNTech COVID-19 mRNA vaccine of interest
  • Biological: Pfizer-BioNTech COVID-19 mRNA vaccine
    Pfizer-BioNTech COVID-19 Vaccine, is FDA licensed or authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.
    Other names:
    • Pfizer-BioNTech COVID-19 Vaccine
Patient did not have a Pfizer-BioNTech COVID-19 mRNA vaccine of interest Patient not located in the vaccine registry having one or more dose of Pfizer-BioNTech COVID-19 mRNA vaccine of interest

Recruiting Locations

More Details

NCT ID
NCT05876377
Status
Active, not recruiting
Sponsor
Pfizer

Detailed Description

We will assess the effectiveness of the COVID-19 vaccine in preventing post-vaccine health conditions. To do this, we will employ a target trial emulation design, examining the vaccine's effectiveness from the time it was authorized or approved, specifically for different age groups, up until the most recent available data. We will gather patient data from HealthVerity, including those enrolled in the claims database, and supplement it with information from the state's deidentified vaccine registry. Only patients eligible to receive the vaccine during the study period will be included in the analysis of post-vaccine health conditions. We will compare vaccinated individuals with those eligible for vaccination but not vaccinated, using various statistical methods such as descriptive statistics, incidence rates, hazard ratios, and survival curves. The second part of our study will use a retrospective cohort design to examine the uptake of the vaccine in specific groups over time. We will identify subjects through two different methods: 1) by analyzing all available dosing records in the Immunization Registry, 2) by using HealthVerity claims data based on specific time periods when the vaccine was available. We will follow these individuals until they receive the vaccine under investigation, leave the study, reach the end of the available data, or pass away. We will assess overall vaccination rates and also analyze the data based on the specific type of prior vaccine dose received.